REAGILA cariprazine (as hydrochloride) 4.5 mg hard capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cariprazine hydrochloride, Quantity: 4.905 mg (Equivalent: cariprazine, Qty 4.5 mg)

Available from:

Gedeon Richter Australia Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: pregelatinised maize starch; magnesium stearate; titanium dioxide; brilliant blue FCF; iron oxide yellow; allura red AC; Gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

60, 30, 90

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

REAGILA? is indicated for the treatment of schizophrenia in adult patients.

Product summary:

Visual Identification: green opaque cap and body which is imprinted in white with 'GR 4.5'; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 60 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-11-18

Patient Information leaflet

REAGILA®
1
REAGILA®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING REAGILA®?
REAGILA contains the active ingredient cariprazine. REAGILA is used to
treat adults with schizophrenia.
For more information, see Section 1. Why am I using REAGILA®? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE REAGILA®?
Do not use if you have ever had an allergic reaction to REAGILA® or
any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become
pregnant or are breastfeeding. Women of childbearing potential must
use effective contraception during and for at least 10
weeks after REAGILA® treatment. REAGILA® is not recommended for use
during pregnancy.
For more information, see Section 2. What should I know before I use
REAGILA®? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines should not be taken with REAGILA® as they may
interfere with how well it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE REAGILA®?
•
FOLLOW ALL DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR OR PHARMACIST
CAREFULLY. They may differ from the information contained in
this leaflet.
More instructions can be found in Section 4. How do I use REAGILA®?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING REAGILA®?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
REAGILA®
•
Call your doctor straight away if you are having any thoughts or
feelings about hurting yourself or to
commit suicide, OR if you have combination of confusion, drowsiness,
muscle stiffness, high fever,
sweating, high blood pressure, fast heartbeat and breathing
(‘neuroleptic malign

Summary of Product characteristics

1
▼
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – REAGILA
®
(CARIPRAZINE) HARD CAPSULES
1
NAME OF THE MEDICINE
Cariprazine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
REAGILA contains cariprazine, a novel atypical antipsychotic agent.
_ _
Each REAGILA
®
hard
capsule contains cariprazine hydrochloride corresponding to 1.5 mg, 3
mg, 4.5 mg or 6 mg of
cariprazine.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Hard capsule that is filled with white to yellowish white powder
mixture.
REAGILA
®
1.5 mg: Hard gelatin capsule with white opaque cap and white opaque
body
imprinted with “GR 1.5” on the capsule body with black ink.
REAGILA
®
3 mg: Hard gelatin capsule with green opaque cap and white opaque body
imprinted with “GR 3” on the capsule body with black ink.
REAGILA
®
4.5 mg: Hard gelatin capsule with green opaque cap and green opaque
body
imprinted with “GR 4.5” on the capsule body with white ink.
REAGILA
®
6 mg: Hard gelatin capsule with purple opaque cap and white opaque
body
imprinted with “GR 6” on the capsule body with black ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
REAGILA
®
is indicated for the treatment of schizophrenia in adult patients.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
REAGILA
®
hard capsules are intended for oral administration only.
REAGILA
®
is to be taken once daily at the same time of the day with or without
food.
The recommended starting dose of REAGILA
®
is 1.5 mg once daily. Thereafter the dose can
be increased in 1.5 mg increments according to efficacy and
tolerability to a maximum dose
of 6 mg/day, if needed. The lowest effective dose should be maintained
according to the
clinical judgement of the treating physician.
Because of the long half-life of cariprazine and its a